Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02639052
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2015-12-18
Brief Title:
Itch Relieving Effect of Botox a Study in Healthy Subjects
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Itch Relieving Effect of Botox a Study in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if Botox is effective in the treatment of an experimentally induced itch that mimics chronic itch in healthy volunteers
Detailed Description:
Several studies have shown that botulinum toxin type A BoNTA has an antipruritic effect due to the inhibition of acetylcholine and other pruritic factors such as substance P and glutamate For instance subcutaneous BoNTA improves itch accompanied to hand eczema dermatitis lichen simplex and rhinitis Furthermore a double-blind placebo-controlled study showed that BoNTA reduced histamine itch intensity in healthy men Since acetylcholine has been shown to mediate itch in atopic dermatitis this study aims to test the itch relieving effect of BoNTA on a non-histaminergic model for chronic itch This non-histaminergic model using the plant cowhage induces itch by activating protease activated receptor 2 PAR2 receptors which play a role in the itch of atopic dermatitis also making this model better suited to test the efficacy of BoNTA to relive chronic itch
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 126938 | OTHER | FDA IND | None |